Senior Quality Assurance Scientist

Job Description

Duties and Responsibilities:

• Provide comprehensive Quality Assurance oversight and support for Reagent manufacturing processes.
• E.g. SOP approvals, equipment record approvals, nonconformances, out of specification events, etc.
• Ensure rigorous adherence to design change procedures, corporate policies, and global regulations (e.g., FDA QSR, ISO).
• Proactively offer guidance and make informed decisions to prevent deviations and non-conformances.
• Collaborate effectively with cross-functional teams to swiftly identify, contain, and disposition non-conforming product.
• Interact proficiently with development, technical operations, and manufacturing personnel to sustain high quality standards, minimize rework and waste, and optimize product satisfaction.
• Establish and drive daily management actions for quality processes, ensuring alignment with broader departmental and organizational initiatives.
• Evaluate quality system performance metrics and lead continuous improvement events to enhance process efficiency and overall effectiveness.

Education and Experience Requirements:

• Bachelor’s degree in a science or engineering discipline with a minimum of 5 years of relevant experience.
• Master’s degree in a science or engineering discipline with a minimum of 3 years of relevant experience.
• Doctoral degree in a relevant field.
• Proven experience performing Quality Assurance functions within a regulated industry.